Our peptide manufacturing lab setup and training include an end-to-end analytical program to confirm the identity, purity, potency, and safety of peptide products, and to train your team to perform and interpret these assays reliably.
Core QC and release testing
- High-resolution reverse-phase HPLC: analytical and preparative purity profiling, peak integration, and stability-indicating methods for routine batch release.
- Mass spectrometry identity confirmation: MALDI-TOF for rapid mass checks and ESI-MS/MS for detailed sequence verification and fragment mapping.
- Standardized QC documentation: release certificates, chromatograms, spectra, and traceable batch records suitable for RUO and GMP workflows.
Extended quantitative characterization
- Amino Acid Analysis (AAA): absolute amino-acid composition and quantitative peptide content for accurate dosing and formulation.
- CHN elemental analysis: carbon, hydrogen and nitrogen determinations to support net peptide content and formulation stoichiometry.
- Residuals and counter‑ion profiling: Karl Fischer or equivalent moisture analysis, residual acid quantification, and ion chromatography for acetate/HCl/other counter‑ion determination.
Safety and regulatory assays
- Endotoxin testing (LAL): quantitative pyrogen assessment with options for kinetic or gel-clot methods depending on sensitivity requirements.
- Bioburden and sterility support: microbial enumeration, advisory sterility testing pathways, and environmental monitoring guidance to support GMP launches.
- Stability and forced‑degradation studies: accelerated and real‑time stability testing, degradant profiling, and shelf‑life recommendations.
Training, method transfer and QA support
- Hands‑on training modules for analysts and QA personnel covering HPLC method setup, MS operation and data interpretation, sample prep, and acceptance criteria.
- Method validation and tech transfer: protocol development, system suitability, method qualification/validation (accuracy, precision, LOD/LOQ, robustness) and transfer to your lab.
- Audit‑ready documentation: SOPs, validation reports, trend analysis, deviation/CAPA templates, and support for preparing for regulatory inspections.
We provide a fully integrated testing service plus practical staff training so your facility can produce, release, and defend high‑quality peptide materials for research, clinical development, and diagnostic use.
